[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33916-33917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11132]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 22-11]


Gary Gray d/b/a Complex; Decision and Order

    On November 22, 2021, the Drug Enforcement Administration (DEA or 
the Agency) issued an Order to Show Cause (OSC) to Gary Gray d/b/a 
Complex (hereinafter, the Respondent) seeking to deny Respondent's 
application for a DEA Certificate of Registration to manufacture 
marihuana, Control No. W14063382E. OSC, at 1.
    After a hearing, the Chief Administrative Law Judge (Chief ALJ) 
issued his Recommended Rulings, Findings of Law, and Decision of the 
Administrative Law Judge (Recommended Decision or RD), which 
recommended Respondent's application for a manufacturing registration 
be denied because ``the plain language of the controlling regulations 
compels the denial of the present application as a matter of law.'' RD, 
at 2, 11. The Agency agrees with the Chief ALJ's recommendation, and, 
for the reasons explained below, denies Respondent's application as 
inconsistent with the public interest under 21 U.S.C. 823(a).\1\
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    \1\ Effective December 2, 2022, the Medical Marijuana and 
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat. 
2257 (2022) (Marijuana Research Amendments or MRA), amended the 
Controlled Substances Act (CSA) and other statutes; however, the 
relevant provision here, 21 U.S.C. 823(a), remained the same.

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[[Page 33917]]

I. Findings of Fact

    On July 30, 2014, Respondent filed an application with DEA to bulk 
manufacture Schedule I controlled substances. Government Exhibit (GX) 
1. According to Respondent, he is seeking to obtain DEA registration as 
a bulk manufacturer of marihuana ``so that he may cultivate, harvest, 
and package the particular strains of marihuana required for his 
research and product development purposes.'' Resp Posthearing, at 4; 
Tr. 30. Respondent hopes to ultimately produce products that will treat 
Alzheimer's and other degenerative diseases. Tr. 30, 49.
    Respondent is a pharmacist and has possessed, and operated under, 
pharmacy controlled substance registrations, as well as having held 
multiple state pharmacy licenses for over 50 years. Tr. 58-61. It is 
undisputed, however, that Respondent does not currently hold any type 
of DEA controlled substance registration, and at the onset of the 
hearing, a certification of Respondent's lack of DEA registration as a 
schedule 1 researcher was admitted into the record without objection. 
Tr. 18; GX 1, at 2.

II. Discussion

    The Controlled Substances Act (CSA) states that the Agency shall 
register an applicant to manufacture controlled substances in schedule 
I or II if such registration is determined to be ``consistent with the 
public interest and with United States obligations under international 
treaties, conventions, or protocols in effect on May 1, 1971.'' 21 
U.S.C. 823(a). The CSA provides six factors DEA must consider in 
determining the public interest. Id. 21 CFR 1318.05, which implements 
the requirements of Sec.  823(a) for marihuana growers and 
manufacturers, further provides that the Agency shall place 
``particular emphasis'' on certain enumerated criteria in determining 
the public interest.
    In situations, such as here, where ``an applicant seeks 
registration to grow cannabis for its own research or product 
development'' one of the criteria of ``particular emphasis'' is that 
``the applicant must possess registration as a schedule I researcher 
with respect to marihuana under Sec.  1301.31 of this chapter.'' 21 CFR 
1318.05(b)(3)(ii) (emphasis added). It is undisputed that Respondent 
does not possess a DEA schedule I researcher registration under Sec.  
1301.31. Tr. 19; Respondent's Exceptions, at 3. Accordingly, under the 
plain language of the regulation, Respondent does not meet the criteria 
to receive the manufacturer registration for which he has applied, and 
the Agency finds that granting his application for a registration would 
not be consistent with the public interest under Sec.  823(a).\2\
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    \2\ Respondent filed Exceptions to the Chief ALJ's Recommended 
Decision arguing that he is eligible for a manufacturer registration 
because he applied for the requisite researcher registration in June 
2022 and that application is pending with DEA. Respondent's 
Exceptions, at 4. Respondent's argument is unpersuasive as the 
regulations clearly state that an applicant must currently possess a 
researcher registration, not just have submitted an application for 
one. (Respondent's application for a researcher registration is also 
not in the record under consideration for this matter as, based on a 
declaration from Respondent's counsel, it was submitted after the 
Chief ALJ had transferred the certified record for this matter to 
the DEA Administrator). Respondent requests, in the alternative, 
that any action on the instant application be stayed pending action 
on his application for registration as a schedule 1 researcher. Id. 
at 6-7. Respondent's request is denied. Respondent may submit a new 
application for a manufacturer registration and that application 
will be evaluated on its merits.
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Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(a), I hereby deny DEA registration application No. 
W14063382E submitted by Gary Gray d/b/a/Complex. This Order is 
effective June 26, 2023.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
May 16, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-11132 Filed 5-24-23; 8:45 am]
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